BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX, AVM

    MDR report key: 842402 · Received April 26, 2007

    Report

    Report Number
    2029214-2007-00026
    Event Type
    Death
    Date Received
    April 26, 2007
    Date of Event
    March 1, 2007
    Report Date
    March 28, 2007
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED.

    Description of Event or Problem · 1

    THIS CASE WAS FOR THE TREATMENT OF A RIGHT PARIETAL BRAIN AVM THAT HAD PREVIOUSLY RUPTURED INTO THE CORPUS CALLOSUM AREA IN 2006. IT WAS REPORTED THAT AN ULTRAFLOW CATHETER AND X-PEDION GUIDEWIRE WERE USED TO GAIN ACCESS TO THE TWO FEEDERS IN THE AVM, AND EACH FEEDER WAS INJECTED WITH ONE VIAL OF ONYX WITH GOOD ANGIOGRAPHIC RESULT. POST TREATMENT, THE PATIENT WAS BROUGHT TO PACU FOR RECOVERY AND A FEW HOURS LATER DEVELOPED A SUDDEN ONSET OF HEADACHE AND VOMITING. CT SCAN WAS PERFORMED AND SHOWED THE PATIENT HAD A MEDIAL BLEED ABOVE THE PREVIOUS RUPTURE. THE PATIENT THEN BECAME HEMIPLEGIC FROM THE BLEED AND WAS INDUCED INTO COMA IN AN ATTEMPT TO CONTROL HER VITALS. FOUR DAYS LATER, THE PATIENT EXPIRED. THE PHYSICIAN BELIEVES THE PROBABLE CAUSE OF THE BLEED WAS A SHIFT OF THE HEMODYNAMIC BALANCE AFTER EMBOLIZING THE AVM. THIS RESULTED IN A LIKELY WEAKENED AREA OF THE AVM TO RUPTURE SEVERAL HOURS POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7000-060 1732540

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death